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The Effect of Minimal Flow Sevoflurane Anesthesia

Primary Purpose

Anesthesia; Functional, Anesthesia Awareness

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Sevoflurane inhalant product

About this trial

This is an interventional treatment trial for Anesthesia; Functional focused on measuring minimal flow anesthesia, laparoscopic cholecystectomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

ASA (American Society of Anesthesiologists) class I-II
The operation time between 60-180 minutes

Exclusion Criteria:

Severe cardiac disease
COPD (Chronic Obstructive Pulmonary Disease)
Severe liver and kidney disease,
Diabetes mellitus
Morbid obesity
Alcohol and/or drug addiction
Risk or history of malignant hyperthermia
Pregnancy and lactation
Emergency cases
Operation time less than 60 minutes and longer than 180 minutes

Sites / Locations

Nebia Peker

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group M

Group H

Arm Description

Group M is minimal flow anesthesia group with fresh gas flow 0,5 L.min-1. Thirty five patients with ASA class I-II and between the ages of 18-65 undergoing elective laparoscopic cholecystectomy will be included. These patients were planned to be administered sevoflurane anesthesia with 0,5 L.min-1 flow under general anesthesia.

Group H is high flow anesthesia group with fresh gas flow 4 L.min-1. Thirty five patients with ASA class I-II and between the ages of 18-65 undergoing elective laparoscopic cholecystectomy will be included. These patients were planned to be administered sevoflurane anesthesia with 4 L.min-1 flow under general anesthesia.

Outcomes

Primary Outcome Measures

CHANGE IN P/F

PaO2/FiO2 ratio is the ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction, not a percentage). P/F ratio is a widely used clinical indicator of hypoxaemia

CHANGE IN PaCO2

The partial pressure of carbon dioxide is the measure of carbon dioxide within arterial blood.

Secondary Outcome Measures

volatile agent consumption amount

the total amount of volatile agent (sevoflurane) consumed at the end of the surgery

Full Information

NCT ID

NCT04813952

First Posted

March 10, 2021

Last Updated

July 17, 2021

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04813952

Brief Title

The Effect of Minimal Flow Sevoflurane Anesthesia

Official Title

The Effect of Minimal Flow Sevoflurane Anesthesia on Blood Gas Analysis and Hemodynamic Parameters in Laparoscopic Cholecystectomies, a Randomised Controlled Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

February 15, 2021 (Actual)

Primary Completion Date

April 30, 2021 (Actual)

Study Completion Date

May 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

Our aim is to investigate the effect of minimal flow anesthesia with sevoflurane on hemodynamics and arterial blood gas parameters in laparoscopic cholecystectomy operations.

Detailed Description

Introduction: Low-flow anesthesia techniques have regained popularity in recent years with the development of low solubility volatile agents such as sevoflurane and desflurane, and modern anesthesia devices. Reducing the flow of fresh gas as much as possible will reduce the amount of volatile agent used, thus preventing air pollution, providing lower costs, and also preserving heat and moisture in the respiratory tract by using rebreathing systems. Laparoscopic surgery is superior to open surgical techniques due to its minimally invasive nature, less postoperative pain, less incidence of wound infections, shortening the hospitalization, and allowing patients to return to their normal lives sooner after the operation. Our aim is to investigate the effect of minimal flow anesthesia with sevoflurane on hemodynamics and arterial blood gas parameters in laparoscopic cholecystectomy operations. Material and Method: Seventy patients with ASA (American Society of Anesthesiologists) class I-II between the ages of 18-65 undergoing elective laparoscopic cholecystectomy were included in the study. After the patients were randomly selected by computer, they were divided into two equal groups as Group M (minimal flow anesthesia group) with fresh gas flow 0,5 L.min-1 and Group C (high flow anesthesia/ control group) with fresh gas flow 4 L.min-1. In both groups. Demographic data, duration of anesthesia, operation times, recovery times, hemodynamic parameters and arterial blood gas parameters of all patients were recorded. The patient data collected in both groups were compared statistically.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anesthesia; Functional, Anesthesia Awareness

Keywords

minimal flow anesthesia, laparoscopic cholecystectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

they will divided into two equal groups as Group M (minimal flow anesthesia group) with fresh gas flow 0,5 L.min-1 and Group C (high flow anesthesia/ control group) with fresh gas flow 4 L.min-1.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group M

Arm Type

Active Comparator

Arm Description

Arm Title

Group H

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Sevoflurane inhalant product

Other Intervention Name(s)

Sevorane

Intervention Description

The sevoflurane dose differed in both groups in relation to the fresh gas flow. Since the fresh gas flow is less in group M, the concentration of sevoflurane consumed by the patient at the end of the case will be less.

Primary Outcome Measure Information:

Title

CHANGE IN P/F

Description

Time Frame

from the beginning to the end of anesthesia

Title

CHANGE IN PaCO2

Description

The partial pressure of carbon dioxide is the measure of carbon dioxide within arterial blood.

Time Frame

from the beginning to the end of anesthesia

Secondary Outcome Measure Information:

Title

volatile agent consumption amount

Description

the total amount of volatile agent (sevoflurane) consumed at the end of the surgery

Time Frame

from the beginning to the end of anesthesia

Other Pre-specified Outcome Measures:

Title

CHANGE IN HR

Description

Heart rate per minute

Time Frame

from the beginning to the end of anesthesia

Title

CHANGE IN MAP

Description

Mean arterial pressure

Time Frame

from the beginning to the end of anesthesia

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ASA (American Society of Anesthesiologists) class I-II The operation time between 60-180 minutes Exclusion Criteria: Severe cardiac disease COPD (Chronic Obstructive Pulmonary Disease) Severe liver and kidney disease, Diabetes mellitus Morbid obesity Alcohol and/or drug addiction Risk or history of malignant hyperthermia Pregnancy and lactation Emergency cases Operation time less than 60 minutes and longer than 180 minutes

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nurcan Coşkun

Organizational Affiliation

Sisli Hamidiye Etfal Training and Research Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Serkan İslamoğlu

Organizational Affiliation

Sisli Hamidiye Etfal Training and Research Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Nebia Peker

City

Şi̇şli̇

State/Province

Istanbul

ZIP/Postal Code

34736

Country

Turkey

12. IPD Sharing Statement

Citations:

PubMed Identifier

27413741

Citation

Doger C, Kahveci K, Ornek D, But A, Aksoy M, Gokcinar D, Katar D. Effects of Low-Flow Sevoflurane Anesthesia on Pulmonary Functions in Patients Undergoing Laparoscopic Abdominal Surgery. Biomed Res Int. 2016;2016:3068467. doi: 10.1155/2016/3068467. Epub 2016 Jun 20.

Results Reference

result

PubMed Identifier

23277809

Citation

Park SY, Chung CJ, Jang JH, Bae JY, Choi SR. The safety and efficacy of minimal-flow desflurane anesthesia during prolonged laparoscopic surgery. Korean J Anesthesiol. 2012 Dec;63(6):498-503. doi: 10.4097/kjae.2012.63.6.498. Epub 2012 Dec 14.

Results Reference

result

Links:

URL

https://pubmed.ncbi.nlm.nih.gov/27413741/

Description

Effects of Low-Flow Sevoflurane Anesthesia on Pulmonary Functions in Patients Undergoing Laparoscopic Abdominal Surgery

URL

https://pubmed.ncbi.nlm.nih.gov/23277809/

Description

The safety and efficacy of minimal-flow desflurane anesthesia during prolonged laparoscopic surgery

Learn more about this trial

The Effect of Minimal Flow Sevoflurane Anesthesia

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